Identity
- Trade Name
- TRI-BALL FDA UDI
- Generic Name
- Incentive spirometer FDA UDI
- Device Name
- Respiratory Exerciser FDA UDI
- Model / Reference
- L25912000 FDA UDI
- Description
- Respiratory Exerciser FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436020761836 FDA UDI
- 510(k) Number
- K994074 FDA UDI
- FDA Product Code
- BWF FDA UDI
- GMDN Term
- Incentive spirometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Incentive spirometer
Tri-Ball by Leventon Sau — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Incentive spirometer.
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- THRESHOLD — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- AirLife — Airlife, Inc. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Leventon Sau
Sources (1)
- FDA UDI 7ff2cec3-53a1-4d43-af39-f33be6cc12af 34 fields · synced May 30, 2026